BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
Report
- Report Number
- 1119779-2025-00277
- Event Type
- Malfunction
- Date Received
- April 17, 2025
- Date of Event
- March 20, 2025
- Report Date
- May 22, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 30382902451229
- PMA / PMN Number
- K974883
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES. D9. RETURNED TO MANUFACTURER ON: 16-MAY-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY - MATERIAL 245122 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 4213645 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR WAS REVIEWED TO CONFIRM THE FOLLOWING: -THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 4213645. THERE WERE RETENTIONS (100) AVAILABLE FOR INSPECTION. THERE WERE 20/100 RETENTION SAMPLES WITH PARTICLES AT THE BOTTOM OF THE TUBE. THERE WERE FIVE PHOTOS RECEIVED TO ASSIST WITH THE INVESTIGATION OF THIS COMPLAINT. THE PHOTOS SHOWED A CARTON LABEL OF BATCH 4213645 EXP 2026-01-28 AND TUBES WITH WHITE MATERIAL NEAR THE TUBE SENSOR. THERE WERE 65 TUBES RETURNED FROM BATCH 4213645. ALL 65 TUBES SHOWED WHITE SEDIMENT AT THE BOTTOM NEAR THE SENSOR. FIVE RETURNED TUBES WERE INCUBATED AT 20-25 DEGREES CELSIUS AND FIVE RETURNED TUBES WERE INCUBATED AT 33-37 DEGREES CELSIUS. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED. THE SUBCULTURE SEDIMENT WAS INCUBATED INTO TSB TUBES AND INCUBATED AT 33-37 DEGREE CELSIUS. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED. GRAM STAIN WAS PERFORMED AND RESULTED IN NEGATIVE, SHORT RODS. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. THIS COMPLAINT CAN BE CONFIRMED FROM THE RETURNED SAMPLES FOR NONVIABLES. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION DESCRIBED AS "WHITE IMPURITIES" WAS OBSERVED IN SIXTY-FIVE (65) TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED BEFORE USING THE BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, CONTAMINATION DESCRIBED AS "WHITE IMPURITIES" WAS OBSERVED IN SIXTY-FIVE (65) TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30119 | BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | 4213645 | 30382902451229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |